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Hormone Therapy

Mirdametinib for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Ezra Rosen, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days from first day of treatment
Awards & highlights

Study Summary

This trial is testing if mirdametinib is a safe treatment for people with advanced solid tumor cancer that has certain mutations.

Eligible Conditions
  • Breast Cancer
  • Cancer
  • MEK1 Gene Mutation
  • MEK2 Gene Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days from first day of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days from first day of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Treatment/DLT Evaluable Population

Side effects data

From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803
50%
DECREASED APPETITE
30%
CONSTIPATION
30%
DIARRHOEA
30%
PAIN IN EXTREMITY
30%
RASH
20%
NASOPHARYNGITIS
20%
FATIGUE
20%
ANAEMIA
20%
ANGINA PECTORIS
20%
OEDEMA PERIPHERAL
20%
GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%
HEADACHE
20%
COUGH
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
GASTROOESOPHAGEAL REFLUX DISEASE
10%
ASPARTATE AMINOTRANSFERASE INCREASED
10%
BLOOD CREATININE INCREASED
10%
INFLUENZA
10%
NAUSEA
10%
PLATELET COUNT DECREASED
10%
CONTUSION
10%
HYPERTRIGLYCERIDAEMIA
10%
LYMPHOCYTE COUNT DECREASED
10%
DYSPEPSIA
10%
DRY MOUTH
10%
PNEUMONIA
10%
HERPES ZOSTER
10%
ARTHRALGIA
10%
HYPOCALCAEMIA
10%
HYPERKALAEMIA
10%
EYE OEDEMA
10%
BRADYCARDIA
10%
CORONARY ARTERY DISEASE
10%
MYOCARDIAL ISCHAEMIA
10%
PLEURAL EFFUSION
10%
PNEUMOTHORAX
10%
INCREASED TENDENCY TO BRUISE
10%
LEUKOPENIA
10%
NEUTROPENIA
10%
HYPOTHYROIDISM
10%
ABDOMINAL PAIN
10%
ASTHENIA
10%
FACE OEDEMA
10%
PYREXIA
10%
INTERNATIONAL NORMALISED RATIO INCREASED
10%
ARTHRITIS
10%
MUSCLE SPASMS
10%
MUSCULOSKELETAL PAIN
10%
NEURALGIA
10%
INSOMNIA
10%
RESTLESSNESS
10%
DYSPNOEA
10%
DYSPNOEA EXERTIONAL
10%
PRODUCTIVE COUGH
10%
PRURITUS
10%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dovitinib
Dovitinib+Fulvestrant

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 2, Part 2 - mirdametinib as single agentExperimental Treatment1 Intervention
Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 2: dose expansion cohorts
Group II: Arm 2, Part 1 - mirdametinib as single agentExperimental Treatment1 Intervention
Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 1: mirdametinib dose escalation to MTD or RP2D according to the 3+3 design
Group III: Arm 1, Part 2 - mirdametinib in combination with fulvestrantExperimental Treatment2 Interventions
Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 2: dose expansion cohorts where the mirdametinib RP2D will be administered in combination with the standard recommended dose of fulvestrant
Group IV: Arm 1, Part 1 - mirdametinib in combination with fulvestrantExperimental Treatment2 Interventions
Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 1: safety run-in (confirmation of the RP2D for mirdametinib in combination with the standard recommended dose of fulvestrant). This part may include the mirdametinib dose de-escalation according to the 3+3 design if necessary
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirdametinib
2021
Completed Phase 2
~10
Fulvestrant
2011
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,905 Total Patients Enrolled
202 Trials studying Breast Cancer
80,967 Patients Enrolled for Breast Cancer
Ezra Rosen, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05054374 — Phase 1 & 2
Breast Cancer Research Study Groups: Arm 1, Part 1 - mirdametinib in combination with fulvestrant, Arm 1, Part 2 - mirdametinib in combination with fulvestrant, Arm 2, Part 1 - mirdametinib as single agent, Arm 2, Part 2 - mirdametinib as single agent
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT05054374 — Phase 1 & 2
Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05054374 — Phase 1 & 2
~2 spots leftby May 2025
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